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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K946174
Device Name BLOCK(TM) ARTHROSCOPIC TOOL KIT
Applicant
Johnson
5848 Price Rd.
Milford,  OH  45150
Applicant Contact MICHAEL D JOHNSON
Correspondent
Johnson
5848 Price Rd.
Milford,  OH  45150
Correspondent Contact MICHAEL D JOHNSON
Regulation Number888.1100
Classification Product Code
HRX  
Date Received12/19/1994
Decision Date 09/14/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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